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About

The ISO 14155:2026 Good Clinical Practice for Medical Devices Course by Whitehall Training provides a comprehensive guide to the latest international standards for medical device investigations. Aligned with ICH GCP E6(R3) and EU MDR/IVDR, it covers the full study lifecycle from ethical planning to final reporting. Key updates include continuous risk management, the Annex K estimand framework, and formal governance through CECs and DMCs. The curriculum details data integrity via ALCOA++ principles and modern digital solutions like eConsent and EDC validation. It focuses on practical application, ensuring professionals are equipped to manage safety reporting and maintain audit readiness throughout the clinical investigation process.

Course Syllabus

  1. What is ISO 14155?
  2. History & Evolution of ISO 14155
  3. What's New in ISO 14155:2026?
  4. Scope and Application

  1. Key Terms & Definitions — Part 1
  2. Key Terms & Definitions — Part 2

  1. The 14 Principles of Good Clinical Practice
  2. GCP Principles in Practice

  1. Ethical Foundations
  2. Ethics Committee Review
  3. Vulnerable Populations

  1. Informed Consent — Overview
  2. Electronic Consent (eConsent)

  1. Clinical Investigation Planning Framework
  2. The Clinical Investigation Plan (CIP)
  3. Study Types & Designs
  4. The Estimand Framework — Annex K

  1. Risk Management Overview
  2. Device Risks vs. Procedural Risks

  1. Sponsor Responsibilities
  2. Principal Investigator (PI) Responsibilities
  3. CRO Oversight & Delegation

  1. ALCOA++ Data Integrity Principles
  2. Trial Master File (TMF)
  3. Electronic Data Capture (EDC)

  1. Adverse Event Categorisation
  2. Safety Reporting Timelines
  3. Proportionate Safety Reporting

  1. Quality by Design (QbD) in Clinical Investigations
  2. Risk-Based Monitoring (RBM)
  3. Preparing for Regulatory Inspections
  4. Common Audit & Inspection Findings

  1. Study Suspension & Early Termination
  2. Study Close-out Activities

  1. Clinical Events Committees (CECs)
  2. Data Monitoring Committees (DMCs)
  3. Governance Decision Logic

  1. Step 1: Run a Formal Gap Analysis
  2. Step 2: Update QMS & SOPs
  3. Steps 3 & 4: Training and Ongoing Studies

  1. ISO 14155:2026 Annexes — Overview
  2. Annex K: Estimands — Deep Dive
  3. Annex H: Risk Management — Deep Dive
  4. Global Regulatory Alignment
  5. Drug-Device Combination Products
  6. The Clinical Investigation Lifecycle
  7. Key Takeaways from ISO 14155:2026
  8. ISO 14155:2020 vs. ISO 14155:2026 — At a Glance
  9. Glossary of Key Abbreviations
  10. Resources & Further Reading
  11. Course Summary
  12. Assessment & Certification

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Frequently Asked Questions

The ISO 14155:2026 course by Whitehall Training provides a comprehensive foundation for professionals by combining international GCP standards with the specialized requirements of medical device clinical investigations. It covers the full study lifecycle, from ethical planning and Clinical Investigation Plan (CIP) development to safety reporting and study close-out. Key focus areas include continuous risk management, the Annex K estimand framework, and formal governance through CECs and DMCs. The curriculum emphasizes data integrity using ALCOA++ principles and prepares participants for regulatory inspections through robust Trial Master File (TMF) maintenance. By aligning with EU MDR, FDA, and ICH GCP E6(R3) frameworks, the course equips teams with the practical skills needed to ensure participant safety and scientific data validity in a regulated environment.

  • Core principles of ISO 14155:2026 and Good Clinical Practice for medical device investigations
  • Clinical investigation lifecycle including planning, conduct, and close-out
  • Development and application of Clinical Investigation Plans (CIP)
  • Continuous risk management integrated with ISO 14971
  • Safety reporting requirements (AE, SAE, USADE) and reporting timelines
  • Data integrity principles including ALCOA++ and TMF management
  • Governance structures including CECs and DMCs
  • Modern approaches such as eConsent and risk-based monitoring

This course is ideal for professionals involved in medical device clinical investigations, including:

  • Clinical Affairs and Regulatory Affairs professionals
  • Quality Assurance and compliance teams
  • Principal Investigators and clinical site staff
  • CRO professionals and clinical project managers
  • Anyone seeking to understand ISO 14155:2026 requirements and GCP for medical devices
No prior experience with ISO 14155 is required, but basic knowledge of clinical research or GCP is beneficial.

  • Comprehensive training aligned with ISO 14155:2026 international standard
  • Updated with latest regulatory expectations including ICH GCP E6(R3), EU MDR/IVDR, and FDA guidelines
  • Practical guidance on risk management, safety reporting, and audit readiness
  • Covers new 2026 updates including Annex K estimands and governance frameworks
  • Enhances understanding of data integrity and inspection preparedness
  • Certificate issued upon successful completion